Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on the Effectiveness of Pembrolizumab with Chemotherapy in Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Levels

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for non-small cell lung cancer (NSCLC), a type of lung cancer. The study will explore the effectiveness of different medications, including Cisplatin, Pemetrexed, Pembrolizumab (also known by its code name MK-3475), Paclitaxel, and Carboplatin. These medications are administered as solutions for infusion, which means they are given directly into the bloodstream through a vein.

The purpose of the study is to assess and compare the effectiveness of two treatment strategies for patients with advanced NSCLC that have a high level of a protein called PD-L1. The study will involve a series of treatments over a period of time, with some patients receiving a combination of medications and others receiving a single medication. The study will also include a group of patients who will receive a placebo. The goal is to determine which treatment strategy is more effective in controlling the disease.

Participants in the study will receive treatment over several weeks, with regular monitoring to assess how well the treatment is working. The study will measure various outcomes, such as how long patients live without the disease getting worse and the overall response to the treatment. The study is expected to continue until early 2026, with the aim of providing valuable information on the best treatment options for patients with advanced NSCLC.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the clinical trial, you will attend an initial visit. During this visit, you will undergo a series of tests to confirm your eligibility. These tests will include a review of your medical history, a physical examination, and laboratory tests to ensure your organs are functioning properly.

    You will also be required to provide written informed consent, indicating your understanding and agreement to participate in the trial.

  2. Step 2

    Treatment initiation

    Once eligibility is confirmed, you will begin the treatment phase. The treatment involves receiving medications through an infusion, which is a method of delivering drugs directly into your bloodstream.

    The medications used in this trial include cisplatin, pemetrexed, pembrolizumab, paclitaxel, and carboplatin. The specific combination and dosage will be determined by the study protocol and your medical team.

  3. Step 3

    Ongoing treatment

    Throughout the trial, you will receive regular infusions of the study medications. The frequency and duration of these infusions will be specified by the study protocol.

    You will also have regular follow-up visits to monitor your health and the effectiveness of the treatment. These visits will include physical exams, blood tests, and imaging studies as needed.

  4. Step 4

    End of treatment

    At the end of the treatment phase, you will have a final evaluation to assess your response to the therapy. This will involve similar tests and assessments as conducted during the trial.

    Your medical team will discuss the results with you and provide guidance on any further treatment or follow-up care that may be necessary.

  5. Step 5

    Post-trial follow-up

    After completing the trial, you will continue to be monitored for a specified period. This is to ensure your ongoing health and to gather additional data on the long-term effects of the treatment.

    You will be required to attend follow-up visits and report any changes in your health to the study team.

Who can join the trial?

13 criteria

  • Diagnosis of non-small cell lung cancer (NSCLC) in stage IIIC or IV.
  • Female participants who can have children must agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after the last dose of study medication. This applies to those who have not been surgically sterilized or have not had a period for more than one year.
  • Male participants must agree to use a reliable method of contraception starting with the first dose of study therapy and continuing for 120 days after the last dose.
  • No history of active cancer that requires treatment.
  • Must show adequate organ function as defined by specific medical tests, which should be done within 15 days before starting treatment.
  • Must not have specific genetic changes (driver alterations) for which there is an approved targeted therapy available, such as EGFR, ALK, ROS-1, or BRAF V600E mutations.
  • Tumor must have PD-L1 levels of 50% or higher, determined by a specific lab test using an anti-PD-L1 antibody.
  • Must not have received previous systemic treatment for advanced NSCLC.
  • Must be willing and able to provide written informed consent to participate in the trial.
  • Must be 18 years of age or older on the day of signing the informed consent.
  • Must have measurable disease based on specific criteria (RECIST version 1.1). Lesions in areas that were previously treated with radiation may be considered if they have shown progression.
  • Must have a performance status of 0-1 on the ECOG Performance Scale, which measures daily living abilities.
  • Female participants who can have children must have a negative pregnancy test within 72 hours before receiving the first dose of study medication. If the urine test is positive or unclear, a blood test will be required.

Who cannot join the trial?

5 criteria

  • Patients with any other type of cancer besides non-small cell lung cancer cannot participate.
  • Patients with driver alterations in their cancer cells are not eligible. These are specific changes in the cancer's DNA that can affect how the cancer grows.
  • Patients who do not have MSC-H are excluded. MSC-H refers to a specific characteristic of the cancer cells.
  • Patients with a PD-L1 level less than 50% are not eligible. PD-L1 is a protein that can be found on the surface of cancer cells.
  • Patients who are part of a vulnerable population are not eligible. This means groups of people who might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • ICI-CHT

    is a combination of immune checkpoint inhibitors and chemotherapy. Immune checkpoint inhibitors are a type of medication that helps the body's immune system recognize and attack cancer cells more effectively. Chemotherapy involves using drugs to kill or slow the growth of cancer cells. In this trial, the combination of these two therapies is being tested to see how well they work together as a first treatment option for patients with a specific type of lung cancer.

  • ICI-SA

    stands for immune checkpoint inhibitors with supportive agents. This therapy uses immune checkpoint inhibitors, which help the immune system target and destroy cancer cells. Supportive agents are additional treatments that help manage side effects or enhance the effectiveness of the main therapy. This approach is being evaluated to determine its effectiveness as an initial treatment for patients with a certain type of lung cancer.

What is already known about the treatment

  • ICI-CHT

    This medication is administered as an infusion into the bloodstream, typically in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression. The main therapeutic use is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking certain proteins that prevent the immune system from attacking cancer cells. It is classified as an immune checkpoint inhibitor combined with chemotherapy.

  • ICI-SA

    This medication is also given as an infusion into the bloodstream, usually in a medical facility. It is under investigation in clinical trials for its potential to treat advanced non-small cell lung cancer (NSCLC) with high PD-L1 levels. The primary therapeutic goal is to enhance the body's immune response against cancer cells. Its mechanism involves inhibiting proteins that act as brakes on the immune system, allowing it to target and destroy cancer cells more effectively. It falls under the pharmacological category of immune checkpoint inhibitors.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and may spread to other parts of the body, a process known as metastasis. The progression of non-small cell lung cancer can vary depending on the subtype and stage at diagnosis. Early stages may involve localized tumors, while advanced stages often see the cancer spreading to lymph nodes and distant organs. The disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing as it advances.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502253-34-00Estimated enrolment26 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.